Data from T1D Exchange Are Supportive of FDA’s Approval for New Indication for Dexcom G5® Mobile Continuous Glucose Monitoring System

Boston, MA – T1D Exchange, a nonprofit organization accelerating research to improve outcomes in type 1 diabetes, today published a major research study in Diabetes Care that confirms the use of Continuous Glucose Monitoring (CGM) without regular use of confirmatory Blood Glucose Measurements (BGM) is safe and effective.

For years, patients with type 1 diabetes have relied on blood glucose monitoring (BGM), widely known as the finger prick method, to measure their blood glucose levels many times each day and make insulin dosing decisions based on this information. CGM monitors are small wearable devices that automatically capture real-time glucose measures via a sensor that is inserted under the skin and transmits the information wirelessly to a monitoring and display device.

CGM systems can detect and alert patients when they may be at risk of hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose), both of which require intervention to avoid more dangerous complications. Over the past few years, adoption of CGM to monitor blood glucose levels has widely grown, according to T1D Exchange’s Clinic Registry which has health data on 32,000 patients with type 1 diabetes. Specifically, adoption of CGM in the registry cohort has grown from 7% CGM use overall (in analysis completed in 2010–2012) to 21% CGM use overall (in analysis completed during 2014–2015).

The T1D Exchange Replace-BG research study was conceived to better understand how CGM systems are used by patients, how they affect their health outcomes and to build evidence that will be required to support access to and reimbursement of CGM systems. This research is also critical to advance the field of automated insulin delivery. Automated insulin delivery (AID), commonly referred to the “artificial pancreas,” is the evolution of current diabetes management devices to an integrated system incorporating insulin pumps, algorithms, and CGM technology that will allow insulin delivery with little or no input from the patient—thereby relieving a significant burden while improving outcomes.

As the first major study of its kind, T1D Exchange coordinated the multi-center study through its clinic network and enrolled 226 adults with type 1 diabetes. All study participants were provided with a Dexcom’s G4 Continuous Glucose Monitoring System with an enhanced algorithm, which was used for the 6-month duration of the study. Participants were split into two study arms: 149 participants dosed their insulin based on the CGM reading alone without first confirming with a blood glucose meter measurement and 77 were required to confirm the CGM reading with a blood glucose measurement before dosing insulin. Among the major findings of the study is the confirmation there was no difference in outcomes for those using only CGM and those using both CGM and BGM.

“This study is an important step to support regulatory pathways for the automation of insulin delivery for people with type 1 diabetes,” says Dana Ball, executive director and co-founder of T1D Exchange. “These data are supportive of the recent FDA decision to approve the Dexcom G5 indication for insulin dosing and removes a key obstacle that has prevented reimbursement of CGM by Medicare.”

“We are grateful that organizations such as T1D Exchange recognize the need to build evidence around the safety and efficacy of CGM use in treatment decisions,” says Kevin Sayer, president and chief executive officer of Dexcom. “We hope results from this study and the recent FDA decision to expand the indication of the Dexcom G5 system will diminish the hassle and pain of finger stick testing and expand access to CGM technology—ultimately leading to improved control for people with diabetes.”

This study was funded by The Leona M. and Harry B. Helmsley Charitable Trust and CGMs were donated by Dexcom. The research is being presented today at Advanced Technologies and Treatments for Diabetes (ATTD) in Paris, France by principal investigators from the Jaeb Center for Health Research in Tampa, FL, Katrina J. Ruedy, MSPH, and Roy W. Beck M.D., Ph.D., Director, T1D Exchange Clinic Coordinating Center.

“As a practicing endocrinologist, I typically advise my patients who use CGM technology to make treatment decisions based on a BGM reading; however, many of my patients often use CGM readings to make decisions about insulin doses,” stated Grazia Aleppo, MD, Northwestern University and lead author of the study. “The results of this study assures clinicians that patients using CGM for treatment decisions is as safe and effective as BGM.”

About T1D Exchange

T1D Exchange was founded on the belief that people affected by type 1 diabetes need better solutions faster—better treatments and better care. Our nonprofit organization takes an innovative approach that puts the community of people touched by type 1 diabetes at the center of research that will meaningfully impact their lives. Our integrated model offers researchers access to aggregated clinical, biological, patient-reported outcomes and electronic health record data, all while fostering collaboration among patients, physicians, researchers, and industry. Our model is multi-faceted and complex, but our goal is simple: to tangibly improve outcomes for people with type 1 diabetes as fast as humanly possible.

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T1D Exchange pushes the boundary of the traditional research and development model by connecting the experience of living with T1D to the data about the disease. The result is a place where different perspectives are exchanged and faster progress can be made.